Integrated radiation therapy systems and methods for treating a target in a patient

ABSTRACT

An integrated radiation therapy process comprises acquiring first objective target data related to a parameter of a target within a patient by periodically locating a marker positioned within the patient using a localization modality. This method continues with obtaining second objective target data related to the parameter of the target by periodically locating the marker. The first objective target data can be acquired in a first area that is apart from a second area which contains a radiation delivery device for producing an ionizing radiation beam for treating the patient. The localization modality can be the same in both the first and second areas. In other embodiments, the first objective target data can be acquired using a first localization modality that uses a first energy type to identify the marker and the second objective target data can be obtained using a second localization modality that uses a second energy type to identify the marker that is different than the first energy type.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. Patent ApplicationNos. 60/590,525; 60/590,873; and 60/590,872; all of which were filed onJul. 23, 2004, and are herein incorporated by reference in theirentirety.

U.S. patent application Ser. Nos. 09/877,498 filed Jun. 5, 2002, and11/166,801 filed Jun. 24, 2005, are incorporated herein by reference intheir entirety.

TECHNICAL FIELD

This invention relates generally to radiation therapy and moreparticularly to systems and methods that integrate patient assessment,treatment planning, simulation, setup, treatment and/or verificationprocedures to enhance the efficiency and efficacy of the therapy.

BACKGROUND OF THE INVENTION

Cancer is a disease that begins in the cells of a patient. The typicaltreatments for cancer include surgery, radiation, and/or chemotherapy.Because cancer varies from person to person, no single treatment may beeffective for all patients. Typical surgeries for treating cancerinclude cutting, ablating, or otherwise removing an entire body part orjust a portion of a body part where the cancer is located. Surgery,however, is not a viable option for many patients because of thelocation and/or type of cancer. Surgical treatments may also result incomplications with anesthesia or infection, and surgical treatments mayhave long, painful recovery periods. Chemotherapy involves chemicallytreating the cancer. Chemotherapy is not a desirable option for severaltypes of cancers and it can also have many complications.

Radiation therapy has become a significant and highly successful processfor treating prostate cancer, lung cancer, brain cancer and many othertypes of localized cancers. Radiation therapy procedures generallyinvolve (a) assessing the patient to determine a radiation prescription,(b) developing a treatment plan to carry out the prescribed radiation(e.g., dose, beam shape, beam angle, pulse width, etc.), (c) simulatingtreatment according to the treatment plan, (d) setting up a treatmentsession by positioning the patient in a radiation vault such that thetarget is at a desired location relative to the radiation beam, (e)treating the patient in one or more radiation sessions (i.e., radiationfractions) to irradiate the cancer, and (f) verifying or otherwisemanaging the treatment process to assess and modify the radiationsessions. Many radiation therapy procedures require several radiationfractions over a period of approximately 5-45 days. As such, manyaspects of these procedures are repeated over this period and eachprocedure generates a significant amount of data.

To further improve the treatment of localized cancers with radiationtherapy, it is generally desirable to increase the radiation dosebecause higher doses are more effective at destroying most cancers.Increasing the radiation dose, however, also increases the potential forcomplications to healthy tissues. The efficacy of radiation therapyaccordingly depends on both the total dose of radiation delivered to thetumor and the total dose of radiation delivered to normal tissueadjacent to the tumor. To avoid damaging normal tissue adjacent to thetumor, the radiation should be prescribed to a tight treatment marginaround the target such that only a small volume of healthy tissue isirradiated. For example, the treatment margin for prostate cancer shouldbe selected to avoid irradiating rectal, bladder and bulbar urethraltissues. Similarly, the treatment margin for lung cancer should beselected to avoid irradiating healthy lung tissue. Therefore, it is notonly desirable to increase the radiation dose delivered to the tumor,but it also desirable to avoid irradiating healthy tissue.

One difficulty of radiation therapy is that the target often moveswithin the patient either during or between radiation sessions. Forexample, the prostate gland moves within the patient during radiationtreatment sessions because bowel and/or bladder conditions (e.g., fullor empty) displace soft tissue structures within the body. Respirationcan also displace tumors in the prostate gland. Tumors in the lungs alsomove during radiation sessions because of respiration and cardiacfunctions (e.g., heartbeats and vasculature constriction/dialation). Tocompensate for such movement, the treatment margins are generally largerthan desired so that the tumor remains in the treatment volume. This isnot a desirable solution because larger treatment margins generallyresult in irradiating larger volumes of normal tissue.

Conventional radiation therapy procedures address the problem of targetmovement with extensive treatment planning, simulation, setup, andverification procedures. Conventional treatment planning procedures areperformed outside of the radiation vault well before the first radiationfraction. For example, conventional planning procedures typicallyinvolve obtaining CT images of the tumor and implanted gold fiducials todetermine the size, shape and orientation of the tumor. These initial CTimages are often not sufficient for carrying out radiation treatmentsbecause they do not address the internal motion of the tumor. As aresult, patients may also undergo a simulation procedure using adifferent CT scanner that correlates the CT images in a time sequence toreconstruct the three dimensional volume and movement of the tumor.Using this data, the treatment margins can be set based on the observedtrajectory of the tumor within the patient.

Conventional treatment planning procedures can be relatively expensive,require sophisticated equipment and technicians, and restrict thethroughput of patients. For example, CT scanners are very expensivemachines that require dedicated rooms because they use an ionizingenergy for imaging the tumor and the gold fiducials. Additionally, theCT scanners for obtaining the initial images are typically differentthan the CT scanners that are used in the simulation procedures suchthat two separate dedicated areas with very expensive machines arerequired in these applications. Another concern of conventional planningprocesses is that the technicians subjectively interpolate the locationof the tumor and the gold fiducials from the CT scans. This requiresadditional time and expense for skilled personnel, and it is alsosubject to human error. Still another concern of conventional planningprocedures is that shuttling patients from one area to another andaccurately managing the information restricts patient throughput. Thismay result in under utilization of the expensive equipment, facilities,and personnel. Therefore, conventional treatment planning proceduresneed to be improved.

Conventional setup procedures for aligning the tumor with the isocenterof the radiation beam are also an area of concern because they can betime-consuming and subject to error. Current setup procedures generallyalign (a) external reference markings on the patient and/or (b) internalgold fiducials in the patient with desired coordinates of the radiationdelivery device. For example, the approximate location of the tumor isdetermined relative to alignment points on the exterior of the patientand/or gold fiducials in the patient. During setup, the external marksand/or gold fiducials are aligned with a reference frame of theradiation delivery device to position the treatment target at the beamisocenter of the radiation beam (also referenced herein as the machineisocenter).

Conventional setup procedures using external marks may be inadequatebecause the target may move relative to the external marks between thepatient planning procedure and the treatment session and/or during thetreatment session. As such, the target may be offset from the machineisocenter even when the external marks are at predetermined locationsfor positioning the target at the machine isocenter.

Conventional setup procedures using internal gold fiducials are alsogenerally inadequate because this is a time-consuming process that mayproduce inaccurate results. In a typical setup procedure using goldfiducials, a technician positions the patient on a movable table in theradiation vault. The technician then leaves the room and operates anX-ray machine to acquire stereotactic X-rays of the target area. Fromthese X-rays, an offset amount for moving the patient is determined. Thetechnician then moves the table by the offset amount and acquires asecond set of stereotactic X-rays to confirm that the position of thetumor is at the machine isocenter. This process may need to be repeatedif the first sequence did not achieve the required placement. Thisprocess is time-consuming and may be unpleasant for the patient becausethe technician must vacate the radiation vault while the X-rays areacquired. This procedure may also be inaccurate because the patient mayinadvertently move after taking the stereotactic X-rays such that thetumor is not at the location in the images. The potential inaccuracy ofthis process may be exacerbated because a person typically determinesthe offset by subjectively interpolating the CT images. Therefore,conventional setup procedures using gold fiducials tie up expensivelinear accelerators in the radiation vault for extensive periods of timejust to position patients for treatment, and conventional setupprocedures may be inaccurate.

Another aspect of current radiation therapy techniques is to verify theperformance of the radiation fraction and assess the status of the tumorfor managing subsequent treatment fractions. Conventional verificationsystems record the status of the hardware of the radiation deliverydevice during a radiation session. For example, conventionalverification systems record the beam intensity, beam position, andcollimator configuration at time intervals during a radiation fraction.The hardware information from the radiation delivery device is then usedto estimate the radiation dosage delivered to discrete regions of thetumor. Such conventional verification procedures, however, are subjectto errors because the tumor is assumed to be at the machine isocenterthroughout the radiation fraction. Moreover, the tumor is generallyassumed to have the same size, shape and trajectory as determined in theplanning procedure. The actual dosage delivered to the tumor may besignificantly different because the tumor typically moves during theradiation fraction, or the tumor may have changed shape or trajectoryafter several radiation fractions because of the effects of theradiation. In conventional radiation therapy systems, the changes inshape or trajectory of the tumor can be determined using additional CTscans, but this requires additional time and use of expensive CTscanners and personnel. CT scans also expose the patient to moreradiation. Therefore, conventional verification procedures can also beimproved.

Another challenge of providing radiation therapy is that the informationfrom the planning, simulation, setup, treatment, and verificationprocedures is typically generated from different equipment in variousformats. Each stage of the process typically uses a stand-alone systemthat has unique formats/protocols that do not communicate with systemsused at other stages of the process. This is inefficient becausemanaging the data from the different procedures in a coherent,integrated manner may be difficult. For example, information from the CTscans, treatment plans, and the radiation sessions may be generated fromequipment that uses different formats and/or protocols that are notcompatible with each other. The information may accordingly need to bemanaged using some manual input or control. As such, expensive equipmentand highly trained technicians are often under utilized becauseinformation is not readily available.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram illustrating an integrated system forradiation therapy in accordance with an embodiment of the invention.

FIG. 2 is a flow diagram of an integrated process for radiation therapyin accordance with an embodiment of the invention.

FIG. 3 is a flow diagram of a planning/simulation procedure performed aspart of a radiation therapy process in accordance with an embodiment ofthe invention.

FIG. 4 is a flow diagram of setup and treatment procedures for aradiation therapy process in accordance with an embodiment of theinvention.

FIG. 5 is a flow diagram of record/verification and adaptive treatmentplanning procedures for a radiation therapy process in accordance withan embodiment of the invention.

FIG. 6 is a flow diagram of a procedure for cataloging results ofradiation fractions and treatment plans for a radiation therapy processin accordance with an embodiment of the invention.

DETAILED DESCRIPTION

A. Overview

FIGS. 1-6 illustrate specific embodiments of systems and methods forintegrating radiation therapy procedures in accordance with theinvention. These embodiments of the systems and methods are generallydescribed with respect to localizing units that periodically locate amarker positioned within a patient with respect to an external referenceframe outside of the patient. For example, the localizing units can usea wirelessly transmitted magnetic field and a marker with a transponderthat wirelessly transmits location signals in response to the magneticfield. It will be appreciated that this type of localizing unit usesnon-ionizing magnetic energy to locate the marker, but that other typesof non-ionizing energy, such as ultrasound, RF, etc., may also be usedin some circumstances. Several embodiments of the invention may alsoimage or otherwise identify the markers using an ionizing energy inconjunction with or in lieu of periodically localizing the markers usinga non-ionizing energy.

In several embodiments, the integrated systems localize at least oneimplanted marker during several different stages of the therapy processto provide objective target data in a common format that can becommunicated and used throughout the implanting, planning, simulation,setup, treatment, and verification procedures. The objective target datacan also be used for modifying any of these procedures. Severalembodiments of the integrated methods and systems implant or otherwiseposition a marker within the patient and track the marker using anon-ionizing energy throughout substantial portions of the process byperiodically locating the marker. Several such markers are generallytracked when the patient is in the radiation vault and/or other areas ofa facility by localizing units that periodically locate the markers inan external reference frame. The tracked locations of the markers can beused to monitor and evaluate the status of the target at many stagesthroughout the radiation therapy process without utilizing expensiveequipment and rooms within the facility. As a result, the integratedmethods and systems are expected to provide a high degree of efficiencyand enhance the efficacy of radiation therapy.

One embodiment of an integrated process for treating a target in apatient comprises acquiring first target data by locating a marker in areference frame external to the patient using a marker localizationmodality. The marker is positioned within a patient relative to a targetthat is to be irradiated or otherwise treated with an ionizing radiationbeam. This method continues with obtaining second target data bylocating the marker using the marker localization modality while thepatient is at a radiation delivery device that produces the ionizingradiation beam. Additional stages of this method include irradiating thepatient with the ionizing radiation beam while obtaining the secondtarget data using the marker localization modality, acquiring hardwaredata related to the radiation delivery device, and evaluating theradiation delivered to the patient using the first target data, thesecond target data, and/or the hardware data. The external referenceframe in which the first target data is located can be any referenceframe that is external to the patient. For example, the externalreference frame can be based on a sensor array or other type of devicepositioned outside of the patient that acquires signals or otherinformation related to the position of the marker relative to theoutside device. The external reference frame can alternatively be areference frame in a room or other fixed reference frame outside of thepatient. The marker localization modality for acquiring the first targetdata and obtaining the second target data typically uses the same typeof energy for acquiring the target data. For example, the energy couldbe an ionizing energy (e.g., kilovoltage or megavoltage X-rays) or anon-ionizing radiation (magnetic, ultrasound, or other suitableelectromagnetic radiation). The hardware data related to the radiationdelivery device can include data regarding the position, presence orother attribute of the table supporting the patient, the gantryposition, any aspect related to the radiation beam, accessories that areused on and/or around the patient, and any other device in the radiationvault associated with the radiation delivery device.

Another embodiment of an integrated radiation therapy process comprisesacquiring first objective target data related to a parameter of a targetwithin a patient by periodically locating a marker positioned within thepatient using a localization modality located in a first area. The firstarea, for example, is apart from a second area that contains a radiationdelivery device which produces an ionizing radiation beam for treatingthe patient. This method continues with obtaining second objectivetarget data related to the parameter of the target by periodicallylocating the marker using the localization modality in the second area.

Another embodiment of an integrated radiation therapy process comprisesacquiring first objective target data related to a parameter of a targetwithin a patient by periodically locating a marker positioned within thepatient using a first localization modality that uses a first energytype to identify the marker. This method continues with obtaining secondobjective target data related to the parameter of the target byperiodically locating the marker using a second localization modalitythat uses a second energy type to identify the marker that is differentthan the first energy type. For example, the marker can be identified ina CT scan or other type of X-ray using a first localization modalitythat uses ionizing energy to identify the marker. The second objectivetarget data can be obtained by using a second localization modality thatuses a magnetic field to identify the same marker either concurrentlywith acquiring the first objective target data or at a different pointin time.

Another embodiment of a method of integrated radiation therapy comprisesacquiring objective planning data related to a parameter of a targetwithin a patient by periodically locating a marker positioned within thepatient using a localization modality. This method continues withobtaining objective in-situ data related to the parameter of the targetby periodically locating the marker with the localization modality whilethe patient is at a radiation delivery device that produces the ionizingradiation beam. This method further includes determining a parameter ofthe radiation delivered to the patient using the in-situ data.

Another embodiment of a method of integrated radiation therapy comprisesperforming a treatment planning procedure, performing a set upprocedure, and performing a radiation treatment fraction. The treatmentplanning procedure includes (a) obtaining images of a target within apatient and of a marker positioned within the patient proximate to thetarget using an imaging modality, (b) acquiring first target data byperiodically locating the marker with respect to a reference frameexternal to the patient using a localization modality, and (c)developing a treatment plan using the images and the first target data.The set up procedure includes (a) determining locations of the markerwith respect to a machine isocenter of a radiation delivery device byperiodically locating the marker in a radiation vault containing theradiation delivery device using the localization modality, and (b)moving the patient to align the target relative to the machine isocenterbased on the determined locations of the marker. The radiation treatmentfraction includes irradiating the patient according to the treatmentplan while periodically locating the marker in the radiation vault usingthe localization modality.

Still another embodiment of a method of integrated radiation therapycomprises acquiring objective planning data related to a parameter ofthe target within a patient by periodically locating a marker positionedwithin the patient using a portable localization system at a treatmentplanning area. This method further includes moving the portablelocalization system to a radiation vault containing a radiation deliverydevice separate from the treatment planning area, and determininglocations of the marker with respect to a machine isocenter of theradiation delivery device by periodically locating the marker in theradiation vault using the portable localizing system.

A further aspect of the present invention is directed toward methods fortreating a target within a patient using radiation therapy. Oneembodiment of such a method includes developing a treatment plan forcontrolling a radiation delivery device to treat a target with a beam ofradiation, and operating the radiation delivery device according to thetreatment plan to irradiate the target. This method further includesperiodically locating a marker positioned within the patient with alocalization system using non-ionizing energy to determine locations ofthe marker in a reference frame external to the patient, and determininga parameter of the target based on the locations of the marker in thereference frame. This method also includes adapting and/or confirmingthe treatment plan based at least in part on the determined parameter ofthe target.

Another aspect of the invention is directed toward methods forestablishing systems for radiation therapy. One embodiment of such amethod includes providing a first node having a first localizing unitlocated in a first area of a facility, providing a second node having asecond localizing unit located in a radiation vault containing aradiation delivery device, and operatively coupling the first node tothe second node by a network to transfer target data between the firstand second nodes. The first localizing unit at the first node, forexample, is configured to locate a marker positioned within the patientwith respect to a reference frame external to the patient. The secondlocalizing unit of the second node, is configured to locate the markerpositioned within the patient with respect to a reference frame of theradiation delivery device.

Additional aspects of the invention are directed toward systems forradiation therapy. One embodiment of such a system comprises a firstnode having a first localizing unit located in a first area of afacility, a second node having a second localizing unit located in aradiation vault containing a radiation delivery device, and a networkoperatively coupling the first node to the second node to transfertarget data between the first and second nodes. The first localizingunit is configured to locate a marker positioned within the patient withrespect to a reference frame external to the patient. The secondlocalizing unit is configured to locate the marker positioned within thepatient with respect to a reference frame of the radiation deliverydevice.

Another embodiment of a method for integrated radiation therapycomprises acquiring first objective target data related to a parameterof a target by tracking markers implanted in the patient using atracking modality located in a first area of a facility. This method cancontinue by obtaining second objective target data related to theparameters of the target by tracking the markers using the same trackingmodality in a second area of the facility that contains a radiationdelivery device. For example, the first objective target data can beobtained by tracking the markers using an alternating magnetic field inan observation area of the facility, and the second objective targetdata can be obtained using the same localizing unit or a similarlocalizing unit that uses an alternating magnetic field in the radiationvault. The objective target data can include the relative locationsbetween the markers and/or the locations of the markers relative to amachine isocenter in the radiation vault. As such, the configuration ofthe target, the trajectory of the target, and/or the location of thetarget relative to the machine isocenter can be determined throughoutthe facility and while a technician is present with the patient.

Another aspect of integrated radiation therapy is a method fordeveloping a treatment plan for treating a target within a patient. Anembodiment of this method includes tracking markers implanted in thepatient with a localizing system using non-ionizing energy to determinelocations of the markers in a reference frame. This method can furtherinclude determining a physical parameter of the target within thepatient based on the locations of the markers in the reference frame.The physical parameter, for example, can be the target configurationand/or the target trajectory.

Still another aspect of integrated radiation therapy is a method forintegrating planning and treatment procedures. One embodiment, forexample, includes positioning a target relative to a machine isocenterin a radiation vault containing a radiation delivery machine. Thedesired location of the target is defined by the treatment plan. Afterpositioning the target, this method proceeds by irradiating the patientwith a radiation beam from the radiation delivery device. This methodalso includes tracking locations of markers implanted within the patientfor at least a substantial portion of the time while the patient isbeing positioned and/or irradiated in the radiation vault.

Several of the procedures described below with reference to FIGS. 1-6may have additional steps or stages, and other embodiments of theinvention may not include some of the steps/stages illustrated in FIGS.1-6. Additionally, other embodiments of systems and methods forintegrating radiation therapy in accordance with the invention aredescribed and/or claimed, but not necessarily illustrated in FIGS. 1-6.A person skilled in the art, however, will understand that the inventionmay be practiced without several of the details shown and described withreference to FIGS. 1-6, or that additional details can be added to theinvention. Where the context permits, singular or plural terms may alsoinclude the plural or singular term, respectively. Moreover, unless theword “or” is expressly limited to mean only a single item exclusive fromother items in reference to a list of at least two items, then the useof “or” in such a list is to be interpreted as including (a) any singleitem in the list, (b) all of the items in the list, or (c) anycombination of the items in the list. Additionally, the term“comprising” is used throughout to mean including at least the recitedfeature(s) such that any greater number of the same features and/ortypes of other features and components are not precluded.

B. Embodiments of Integrated Radiation Systems

FIG. 1 schematically illustrates an integrated system 10 for radiationtherapy including a planning/simulation module 12, a treatment module14, and a record/verification module 16. In the embodiment shown in FIG.1, the planning/simulation module 12, treatment module 14, andrecord/verification module 16 are located in separate areas of afacility. In other embodiments, the record/verification module 16 can belocated with the planning/simulation module 12 or treatment module 14.The planning/simulation module 12, treatment module 14, and verificationmodule 16 can each have a computer, and these modules can be operativelycoupled together by a network 18. The integrated system 10 can alsoinclude a separate computer 19 either in lieu of or in addition to thecomputers in each of the individual modules. The computer 19, forexample, can be a central information system that manages the data fromimaging units (CT scanners), localizing units, radiation deliverydevices, and record/verification equipment. In alternative embodiments,a central information system can be part of one of the modules 12, 14 or16 instead of a separate computer. As described in more detail below,the integrated system 10 provides objective target data from at leastone of the modules that is stored, communicated, and/or used by at leastone of the other modules to carry out the radiation therapy.

The planning/simulation module 12 in the embodiment illustrated in FIG.1 includes an imaging area 20 containing an imaging unit 22 and anobservation area 24 including a localizing unit 26. The imaging area 20and the observation area 24 are typically separate rooms in a facility,but the localizing unit 26 and the imaging unit 22 can be in the sameroom. The imaging unit 22 uses an imaging modality that provides imagesshowing tumors, lesions or other targets within the patient. CT imagers,for example, use ionizing energy to provide a three-dimensionalrepresentation of a tumor or other type of soft tissue lesion, and CTimages also identify radiopaque markers implanted in the patient. Theimaging unit can alternatively be an X-ray machine, magnetic resonanceimaging (MRI) machine, or ultrasound system. The imaging unit 22 canaccordingly use ionizing radiation or non-ionizing radiation to acquireimages of the target and the markers implanted in the patient.

The localizing unit 26 tracks at least one marker positioned within thepatient using a localization modality. The localization modality of thelocalizing unit 26 is often different than the imaging modality of theimaging unit 22. The localizing unit 26, for example, can have alocalization modality that uses a non-ionizing energy to periodicallydetermine the locations of implanted markers relative to an externalreference frame of the localizing unit or another external referenceframe outside of the patient. The imaging unit 22, on the other hand,can have a localization modality that uses an ionizing energy to obtainX-rays or CT scans. Because the localizing unit 26 uses a non-ionizinglocalizing modality, other people can be proximate to the patient whilethe localizing unit 26 operates. The external reference frame in whichthe markers are located is any reference frame external to the patient.For example, the external reference frame can be a sensor or imagingarray outside of the patient, or it can be a reference frame defined bya room or radiation delivery device.

The planning/simulation module 12 can further be used for performing asimulation procedure in the imaging area 20 and/or the observation area24. A treatment plan is typically developed from at least the imagesobtained in the imaging unit 22, but the treatment plan may also includeinformation from the localizing unit 26. The localizing unit 26, forexample, can provide additional information for determining how todeliver the radiation prescribed for the patient based at least in parton the locations of the markers. In one embodiment, the radiationtreatment is simulated using a series of CT images in a time sequence,or in another embodiment the treatment is simulated by periodicallydetermining the locations of markers within the patient using thelocalizing unit either in lieu of or in addition to the CT images. Asexplained below, the results of the simulation procedure can be used torevise the treatment plan or provide additional information for theradiation treatments.

In one embodiment, the localizing unit 26 periodically locates orotherwise tracks small markers having transponders that produce magneticfields in response to magnetic excitation fields at the resonantfrequencies of the transponders. The localizing unit 26, for example,can include an excitation source that generates and wirelessly transmitsthe alternating magnetic excitation field to the implanted markers. Thelocalizing unit 26 can further include a sensor assembly configured toreceive a wirelessly transmitted location signal from the markers, areceiver for processing signals from the sensor assembly, and a computerfor calculating the three-dimensional coordinates of the markers in areference frame. Specific localizing units with magnetic localizers aredescribed in the following U.S. Patent Applications, each of which isincorporated herein by reference in its entirety: U.S. patentapplication Ser. No. 10/344,700 filed Dec. 30, 2002; U.S. patentapplication Ser. No. 10/027,675 filed Dec. 20, 2001; U.S. patentapplication Ser. No. 10/213,980 filed Aug. 7, 2002; U.S. patentapplication Ser. No. 10/679,801 filed Oct. 6, 2003; U.S. patentapplication Ser. No. 10/382,123 filed Mar. 4, 2003; U.S. patentapplication Ser. No. 10/746,888 filed Dec. 24, 2003; and U.S. patentapplication Ser. No. 10/749,478 filed Dec. 31, 2003.

The treatment module 14 is typically a radiation vault having aradiation delivery device 30 and a localizing unit 32. The radiationdelivery device 30 is a linear accelerator or other type of device thatuses ionizing radiation to destroy tumors or other types of targets.Suitable linear accelerators are manufactured by Varian Medical Systems,Inc. of Palo Alto, Calif.; Siemens Medical Systems, Inc. of Iselin, N.J.Oklahoma; Elekta Instruments, Inc. of Crawley, Okla.; or MitsubishiDenki Kabushik Kaisha of Japan. Such linear accelerators can deliverconventional single-field or multi-field radiation therapy, 3D conformalradiation therapy (3D CRT), intensity modulated radiation therapy(IMRT), stereotactic radiotherapy, and tomotherapy. The radiationdelivery device can deliver a gated, contoured, or shaped beam ofionizing radiation from a movable gantry to an area or volume at a fixedlocation in a reference frame relative to the radiation delivery device.The volume to which the ionizing radiation beam is directed is referredto as the machine isocenter.

The localizing unit 32 can be substantially the same as the localizingunit 26 used for treatment planning and/or simulation. In someapplications, in fact, a portable localizing unit can be moved from theplanning/simulation module 12 to the treatment module 14 such that onlya single localizing unit is used in the integrated system 10. Thelocalizing unit 32 determines the actual positions of the markers inreal-time while setting the patient up in the radiation delivery device30 and while irradiating the target with the ionizing radiation. Morespecifically, the localizing unit 32 periodically determines thethree-dimensional coordinates of the markers in real-time throughout thepatient setup process and/or while irradiating the patient. Thereal-time marker locations are objective data that can be used todetermine objective target data for controlling the beam or positioningthe patient for dynamic therapy. The marker locations and/or thecorresponding target data derived from the marker locations can also berecorded for subsequent evaluation to verify whether the radiationtherapy has proceeded according to the treatment plan. Specific aspectsof real-time tracking are described in more detail in U.S. applicationSer. No. 11/166,801 incorporated by reference above.

The record/verification module 16 includes an evaluation unit 34 thatreceives the objective target data from the localizing unit 32 andhardware data from the radiation delivery device 30. The evaluation unit34 can receive the data from the treatment module either on-line duringa treatment or off-line after performing a treatment. The evaluationunit 34 can also receive the data from the imaging unit 22 and thelocalizing unit 26 from the planning/simulation module 12. Theverification module 16 can assess the performance of the radiationtherapy to provide an early indicator of changes in the configuration ofthe target (e.g., size and/or shape), the trajectory of the targetwithin the patient caused by internal target movement, the dosage ofradiation applied to the target, and/or other parameters. One aspect ofthe integrated system 10 is that objective target data related to themarker locations determined by the localizing unit 32 can be (a)correlated with hardware data regarding the status of the radiationdelivery device and/or (b) compared to objective target data from thelocalizing unit 26 to provide a significant amount of information formodifying the treatment plan or otherwise improving the efficacy of theradiation therapy process.

C. Embodiments of Integrated Radiation Therapy Methods

The general practice for treating cancers begins by assessing thepatient to define the type of treatment. For example, a practitionerassesses the patient to determine whether surgery, chemotherapy and/orradiation is the best type of clinical treatment for the patient. Ifradiation therapy is selected as part of the clinical treatment plan, aradiation oncologist determines a radiation prescription for thepatient. For example, the radiation oncologist prescribes the number ofradiation fractions, dose, and other parameters of the radiationtherapy. The radiation oncologist or another practitioner then educatesthe patient about the options for implementing the radiation therapy,the patient's role in effectuating the treatment, and the ramificationsof radiation therapy. The patient is then enabled for carrying out theintegrated processes of radiation therapy in accordance with severalembodiments of the invention. For example, a patient can be enabled byimplanting or otherwise positioning a marker within the patient that canbe tracked or at least periodically located using the localizing units26 and/or 32. These markers may also be identified in images using anionizing radiation. One or more markers are usually positioned withinthe patient by (a) implanting the markers in the patient relative to thetarget, (b) incorporating a marker in a bite block that the patientclamps between his/her teeth, or (c) otherwise securing a marker withinthe patient such that the marker is not optically accessible via adirect line-of-sight from outside of the patient. After the patient hasbeen enabled, the patient is ready for radiation therapy in accordancewith several methods of the invention.

FIG. 2 is a flow diagram of an integrated process 100 for radiationtherapy in accordance with an embodiment of the invention. Theintegrated process 100 provides objective data that can be communicatedand used at several nodes or modules throughout a facility. Theintegrated process 100 generally begins with a treatment planningprocess (Block 102) for determining how the radiation prescription willbe effectuated. For example, the treatment planning process can includedeveloping a model of a target within the patient and/or determining theradiation beam parameters of the treatment fractions. The treatmentplanning procedure, more specifically, can include obtaining imagesusing a CT scanner or another suitable imaging modality that show thetarget configuration and the relative positions between the target andmarkers positioned within the patient. The coordinates of the target andof each marker relative to the external reference frame of the CTscanner are recorded and stored in a memory device. When the markers canbe localized using a non-ionizing energy, it is possible that only asingle CT scan may be necessary for developing a treatment plan andtreating a patient. However, several CT scans will generally be used inmost applications. Additional details of specific embodiments of thetreatment planning procedure are described below with reference to FIG.3.

Referring to FIG. 2, the integrated process 100 can optionally include asimulation procedure (Block 104) that simulates the treatment bymonitoring the physical parameters of the target to confirm or modifythe treatment plan. For example, the localizing unit 26 can track one ormore markers positioned within the patient to determine the rotation andtrajectory of the target while the patient undergoes a mock treatment inwhich the patient is positioned according to the treatment plan. Thesimulation procedure can further include training the patient usingbiofeedback responses so that the patient learns to breath or otherwisecontrol his/her body in a manner that provides better control of thetreatment margins and other parameters. As explained in more detailbelow with reference to FIG. 3, the simulation procedure can beperformed before, during and/or after developing the treatment plan toprovide more information for developing or modifying the treatment plan.

Referring to FIG. 2, the integrated process 100 further includes a setupprocedure (Block 110) that includes positioning the patient in theradiation vault so that the target is at a desired location with respectto the machine isocenter of the radiation delivery device 30 (FIG. 1).The setup procedure is performed when the patient is on a support tablein the radiation vault at the beginning of each radiation session. Thelocalizing unit 32 (FIG. 1) (a) tracks or otherwise locates the markersperiodically and (b) computes an offset between the actual position ofthe target and the desired position of the target for radiationtreatment. In manual applications, a technician then moves the supporttable according to the calculated offset and verifies that the target isat the desired location using the localizing unit 32. In automaticapplications, the localizing unit 32 sends a signal to the computer 19(FIG. 1) or directly to the radiation delivery device 30 that causes theradiation delivery device 30 to move the table according to thecalculated offset until the target is positioned at the desired targetlocation with respect to the machine isocenter. In either application,the technician can be in the room with the patient while the markers arelocalized. This is expected to significantly reduce the setup timebecause the technician does not need to leave the room to determine thelocation of the target with respect to the machine isocenter as iscurrently required by conventional systems that use an ionizingradiation for positioning the patient. Several specific embodiments ofthe setup procedure are described in greater detail with reference toFIG. 4.

The integrated process 100 continues with a treatment procedure (Block120) in which the patient is irradiated with a radiation beam from theradiation delivery device 30. The treatment procedure is typically asingle treatment fraction that delivers a portion of the total plannedradiation dosage. Many integrated radiation therapy processes requireseveral treatment fractions to provide the desired dosage to the target.Several details of the treatment procedure are also described in greaterdetail below with reference to FIG. 4.

The integrated radiation therapy method 100 further includes a treatmentmanagement and verification procedure (Block 130) that quantifies theresults of the radiation fractions, assesses whether the patient hasbeen irradiated according to the treatment plan, and/or providesinformation for modifying the plan when appropriate. In the verificationprocedure, the evaluation unit 34 (FIG. 1) receives hardware data fromthe radiation delivery device 30 or other device related to theradiation delivery device. The evaluation unit 34 can also receiveobjective target data, such as location information of the target and/ormarkers from the localizing units 26 and 32 via the network 18 (FIG. 1).The evaluation unit 34 can perform several functions. For example, theevaluation unit 34 can correlate the status of the radiation deliverydevice 30 with the recorded locations of the target over sequential timeintervals of the treatment procedure. This correlation between themachine status and the target location can be used to determine theradiation dose applied to discrete regions of the target and healthytissue proximate to the target. The verification procedure can alsodetermine other parameters of the target, such as the targetconfiguration and target trajectory to provide an early indicator ofwhether the target has changed.

The integrated radiation therapy process 100 continues with a firstdecision (Block 140) and a second decision (Block 142). The firstdecision (Block 140) determines whether the treatment is complete. Ifthe treatment is complete through all of the radiation fractions, thenthe process terminates at the end (Block 150). However, if the treatmentis not complete, the process continues to the second decision (Block142) which determines whether the treatment plan should be adapted tocompensate for changes in the target, dosages delivered to discreteregions of the target, or other aspects of the treatment. If the currenttreatment plan is appropriate, the process 100 continues by repeatingthe setup procedure (Block 110), treatment procedure (Block 120), andverification procedure (Block 130) at the next radiation treatmentsession for the patient (typically one day or several days later).However, if the verification procedure indicates that the treatment planshould be changed, the integrated process 100 returns to the treatmentplanning procedure (Block 102) and/or the simulation procedure (Block104) to redefine or otherwise adapt the treatment plan before proceedingwith the setup and treatment procedures of the next radiation session.

The integrated process 100 illustrated in FIG. 2 provides severaladvantages compared to existing radiation therapy processes. Forexample, the objective target data from the localizing units 26 and 32is communicated and used by the radiation delivery device 30 and theverification module 16. The integrated process 100 accordingly combinesdata from the planning/simulation module 12, the treatment module 14,and the verification module 16 in a manner that enables practitioners tomore accurately assess the status of the tumor and more preciselyposition the tumor at the machine isocenter during therapy procedures.

The simulation procedure (Block 104) of the integrated process 100 alsoprovides several advantages compared to existing simulation proceduresthat use CT scans. For example, the objective target data from thelocalizing unit 26 can be used to quickly determine the trajectory,rotation, shape, size and other parameters of the target without havingto obtain images of the target using a CT scanner. The objective targetdata from the localizing unit 26 is expected to provide an accuraterepresentation of the target parameters that does not rely on subjectiveinterpretation of images. This is expected to enhance the accuracy ofthe simulation procedure. Additionally, because the localizing unit 26uses a magnetic field or other type of non-ionizing energy toperiodically locate the markers and determine the motion/configurationof the target, the simulation procedure does not need to use expensiveCT scanners or subject the patient to additional radiation. Therefore,the simulation procedure of the integrated process 100 providessignificant improvements over conventional simulation procedures.

Several embodiments of the integrated process 100 also efficiently useexpensive imaging equipment and radiation delivery devices so thatfacilities can have a high patient throughput. One aspect of thelocalizing units 26 and 32 is that they frequently monitor the status ofthe target by continuously tracking implanted markers using non-ionizingradiation throughout much of the planning, setup, and treatmentprocedures. By tracking the markers in the normal course of the setupand treatment procedures, the status of the target can accordingly bemonitored without rescanning the patient using the CT scanner. Thisallows the CT scanners and linear accelerators to be used solely forplanning and treating patients, and it also provides early indicators ofchanges in the target (e.g., size/shape and trajectory). Moreover,because a technician can remain with the patient during the setupprocedure and/or the setup procedure can be automated, the setupprocedure can be quite short to process more patients through theradiation vault. Therefore, the integrated process is expected toincrease the efficiency of radiation therapy.

D. Specific Embodiments of Treatment Planning Procedures

FIG. 3 is a flow diagram of a specific embodiment of the treatmentplanning procedure (FIG. 2, Block 102). In this embodiment, thetreatment planning procedure includes an imaging stage 210 in whichimages of the tumor and implanted markers are obtained using CTscanners, ultrasound, MRI or other imaging modalities. As describedabove with reference to FIG. 1, the images are analyzed to determine thecoordinates of the target and the markers in the external referenceframe of the CT scanner. This data is then stored in memory for use inseveral other aspects of the treatment planning procedure, setupprocedure (FIG. 2, Block 110), treatment procedure (FIG. 2, Block 120),and verification procedure (FIG. 2, Block 130). In the case of CTscanners, the imaging stage 210 further requires protecting thetechnician because the imaging modality of the CT scanners uses ionizingradiation to generate the images. As such, the imaging stage isgenerally performed at a separate area such as the imaging area 20 (FIG.1). In some embodiments, the treatment planning procedure can bedeveloped based on images obtained using ionizing energy or non-ionizingenergy (e.g., ultrasound) without tracking the markers using thelocalizing unit 26. In other embodiments the treatment planningprocedure also uses information generated by the localizing unit 26.

When information from the localizing unit is desired, the treatmentplanning procedure continues with a first tracking stage 220 in whichthe localizing unit 26 periodically locates at least one markerpositioned within the patient with respect to an external referenceframe. The localizing unit 26, for example, can continuously track atleast one marker in real time to analyze the motion of the target,and/or it can track at least two markers in real time to characterizethe size/shape of the target. The localizing unit uses a localizationmodality, and in several embodiments the localization modality uses anon-ionizing energy to periodically locate the markers. As explainedabove, the localizing unit 26 is preferably a magnetic localizationsystem that can be used in virtually any observation area of thefacility. For example, the observation area could be a lounge or aprivate cubicle where the markers can be tracked while the patientundergoes a simulation procedure or waits for the setup and treatmentprocedures. The tracking stage 220 acquires objective target data inaddition to the imaging data by tracking the marker with a trackingmodality that can be used in the radiation vault as well.

The treatment planning procedure can optionally include a targetcharacterization/simulation stage 230 comprising determining parametersof the target using the objective target data from the localizing unit26. The characterization/simulation stage 230 can also use images fromthe imaging stage 210. For example, one target parameter that can bemonitored by tracking the markers is the configuration of the tumor. Inthis example, the size/shape of the tumor can be monitored by implantingat least two markers relative to the tumor and tracking the relativedistances between the markers using a magnetic localization system. Thetarget configuration defined by the initial relative positions betweenthe markers is downloaded and stored in memory for comparison withsubsequent measurements. If the size or shape of the target changes,then changes in the relative distances between the markers willcorrespond to changes in the target. The treatment plan can be modifiedor otherwise adapted based on changes in the marker configurations.Another parameter of the target that can be monitored by tracking themarkers is the trajectory and/or rotation of the target within thepatient. In many situations, the target will move along a trajectorywithin the patient because of respiration, bladder filling, or otherreasons. The target trajectory within the patient can be ascertained bytracking the location of at least one marker over sequential timeintervals using the localizing unit 26. The objective target dataregarding the target trajectory can be downloaded and stored in memoryfor use in later processes.

The data provided by the target characterization/simulation stage 230can be integrated into the treatment plan for use in the treatmentmodule 14 and the verification module 16. For example, the trajectory ofthe target measured by the localizing unit 26 can be used to predict theinternal movement of the target during the treatment procedure; this canthen be used to determine the treatment margins and/or beam gating sothat the target is located at a point where the target will reside inthe path of the radiation beam. Another example is that the targetconfiguration provided by the target characterization stage 230 can beused in subsequent comparisons to monitor changes in the target. If thesize and/or shape of the target changes, a corresponding change willoccur in the relative positions between the markers such that thetreatment plan can be modified accordingly.

The treatment planning procedure generally uses information from stages210, 220 and 230 to develop and refine a treatment plan. The imagingstage 210 provides initial images of the target, and the first trackingstage 220 and the characterization/simulation stage 230 provideobjective target data that can be input into the plan. For example, theimages obtained from the imaging stage 210, the objective target dataobtained from the first tracking stage 220, and the data from the targetcharacterization/simulation stage 230 can be used to determine the beamangle, collimator configuration, beam intensity, pulse width, tableposition, and gating operations of a treatment plan.

The treatment planning procedure can optionally include a biofeedbacktraining stage 240. One embodiment of the biofeedback training stage 240includes determining locations of the markers in a reference frame usingthe localizing unit 26 and instructing the patient to control a bodyfunction based upon the tracked locations of the markers. For example,while the localizing unit 26 tracks the markers, a computer can computeand display a representation of the trajectory of the target inreal-time. The patient can watch the display and modulate his/herrespiration to mitigate the target trajectory. As a result, the patientcan be trained to proactively control body functions to maintain thetarget at the desired treatment location in the machine reference frameof the radiation delivery device 30 (FIG. 1).

E. Specific Embodiments of Setup and Treatment Procedures

FIG. 4 is a flow diagram of specific embodiments of the setup andtreatment procedures (FIG. 2, Blocks 110 and 120). In one embodiment,the setup procedure includes a status check to confirm that the targetparameters are still within the specifications of the treatment planbefore irradiating the patient. For example, when the patient arrives atthe treatment facility to undergo a treatment procedure, the patient canbe placed in the observation area 24 (FIG. 1) and the localizing unit 26(FIG. 1) can track the locations of the markers before irradiating thepatient during a treatment procedure. The target trajectory and thetarget configuration can accordingly be determined from the markerlocations. This aspect of the setup procedure can be highly beneficialbecause the target parameters can be confirmed to ensure they match thetreatment plan before irradiating the patient without having to do a CTscan.

The setup and treatment procedures include a second tracking feature 310in which the localizing unit 32 (FIG. 1) tracks the markers in theexternal reference frame of the radiation delivery device 30 (FIG. 1).The second tracking feature typically commences after placing thepatient on a support table under the gantry of the radiation deliverydevice 30 and continues to the end of the treatment procedure. Thelocalizing unit 32 is preferably a magnetic localization system thattracks the markers in the machine reference frame using a non-ionizingenergy to acquire objective target treatment data related to theposition of the target and the parameters of the target.

The setup and treatment procedures further include a positioning stage320 in which the target is positioned relative to the machine isocenterof the radiation delivery device 30. In the positioning stage 320, thelocalizing unit 32 determines the locations of the markers in themachine reference frame and calculates an offset between the actualposition of the target and the desired position of the target relativeto the machine isocenter. The localizing unit 32 then provides anindication of the offset to a technician or a computer to move the tableaccording to the calculated offset. The tracking feature 310 continuesthroughout the positioning stage 320 to continually update the offsetbetween the actual location of a target and the desired position of thetarget relative to the machine isocenter. As such, a technician or anautomatic system continues to move the table according to the calculatedoffset until the target is placed within an acceptable range of thedesired position relative to the machine isocenter. In one embodiment,an alarm can be activated if the actual position of the target deviatesfrom the desired target position after placing the target at the desiredlocation.

The objective target treatment data obtained by the localizing unit 32during positioning stage 320 can further be used to confirm that thetarget configuration and the target trajectory are within thespecifications of the treatment plan shortly before irradiating thetarget with an ionizing beam. This confirmation step can be in lieu ofor in addition to the status check described above. The confirmationstep may be quite useful because sudden changes in the target that wouldotherwise not be identified in conventional processes can be monitoredbefore and during each treatment session. Moreover, patients can getnervous and alter their normal breathing or other functions, and thelocalizing unit 32 can identify when this occurs and provide biofeedbackfor in-situ training of the patient. In one embodiment, an abnormaltrajectory of the target can be noted while the patient is on thesupport table under the gantry, and the patient can be monitored untilthe trajectory of the target is within the planned trajectory from theplanning procedure 102. This is expected to significantly enhance theprecision with which tumors and other types of targets are irradiated.

The tracking feature 310 and the positioning stage 320 are also expectedto significantly enhance the efficiency of the setup procedure (FIG. 2,Block 110). For example, because the technician can remain in theradiation vault with the patient throughout the setup procedure, thetechnician does not waste time traveling between the radiation vault anda shielded area to obtain stereotactic X-rays required by conventionalsystems. Moreover, the tracking feature 310 provides real-time objectiveposition information of the markers that can be sent to a control systemthat automatically moves the support table to position the target at themachine isocenter. The tracking feature 310 can significantly reduce thetime it takes to perform the positioning stage 320 so that more patientscan be treated in the radiation vault per day.

The setup and treatment procedures continue with an irradiation stage330. As explained above, the tracking feature 310 generally continues sothat the location of the target in the machine reference frame can alsobe determined throughout the irradiation stage 330. In manyapplications, the method includes a monitoring feature 340 that operatesconcurrently with the irradiation stage 330 to provide a real-timecorrelation between the actual location of the target and the machineisocenter. The monitoring feature 340, for example, correlates objectivelocation coordinates of the target at sequential time intervalsthroughout the treatment procedure with the radiation beam of theradiation delivery device 30.

The correlation between the target location and the machine isocenterfrom the monitoring feature 340 can be used to perform a dynamicadjustment feature 350 that adjusts a parameter of the radiation beamand/or the patient position in real time during the radiation stage 330.For example, the radiation beam can be terminated when the target movesout of a desired range and activated when the target is within thedesired range (i.e., gated therapy). In another embodiment, the tablesupporting the patient can be moved automatically according to acalculated offset during the radiation stage 330 to maintain the targetwithin a desired range of the machine isocenter. Both of theseembodiments are particularly advantageous for treating lung and prostatecancers because they compensate for target movement caused byrespiration or other body functions during the radiation stage 330. Theobjective target data from the localizing unit 32 can accordingly beintegrated with the radiation delivery device 30 to provide dynamicadjustments to the radiation beam and/or the patient position whileirradiating the patient to mitigate damage to healthy tissue adjacentthe target.

F. Specific Embodiments of Treatment Management and VerificationProcedures

FIG. 5 is a flow diagram illustrating a specific embodiment of theverification procedure (FIG. 2, Block 130). The verification procedurecan include retrieving hardware data regarding the beam status (Block410) and retrieving objective target data from one of the localizingunits. For example, the verification procedure can include retrieving(a) the hardware data and (b) objective target data regarding thecorrelation between the actual location of the target and the machineisocenter (Block 412). The verification procedure further includesdetermining the status of the target (Block 420). In one embodiment, thestatus of the target is determined by correlating the hardware data withthe actual location of the target at sequential time intervals of theirradiation procedure 330 (FIG. 4). The hardware data can include thebeam intensity, beam position, collimator configuration, table position,accessory positions, and/or data related to any other aspect ofequipment in the radiation vault at the sequential time intervals. Thetarget status can be the cumulative radiation received at discrete areasof the target over one or more radiation fractions of the integratedprocess 100. The target status can also be the target configurationand/or the target trajectory throughout the setup procedure and thetreatment procedure. The verification procedure 16 can occur on-linewhile irradiating the patient and/or off-line after completing aradiation fraction.

The verification procedure continues by assessing whether the status ofthe target is progressing according with the treatment plan (Block 430).If the target status is as planned, the procedure continues by repeatingthe setup procedure and the radiation procedure at the next plannedradiation fraction. However, if the target status is not as planned,then the integrated process continues with an adaptive planning stage440 in which the treatment plan is revised to adapt to the change intarget status. After revising the treatment plan in the adaptiveplanning stage 440, the process continues with the setup procedure andthe treatment procedure for the next radiation fraction according to therevised treatment plan.

FIG. 6 is a further aspect of the integrated process that includesstoring the correlations of the actual target locations and the beamstatus in a memory (Block 510) and storing the target status in memory(Block 520). This aspect of the method includes generating a library ofresults over a number of patients that can be easily searched bypractitioners to provide better estimates of the outcomes of specifictreatment plans. A further aspect of this embodiment is to review thelibrary for adjusting the treatment plans based on the observedcharacteristics of previous patients and/or previous radiation fractionsof the same patient.

In general, the terms used in the following claims should not beconstrued to limit the invention to the specific embodiments disclosedin the specification, but rather the invention should be construed toinclude all integrated radiation therapy methods and systems thatoperate in accordance with the claims and any equivalents thereof.Accordingly, the invention is not limited, except as by the appendedclaims.

1. A method of developing a treatment plan for a radiation therapyprogram, comprising: acquiring objective target data related to aparameter of a target in the patient by periodically locating a markerwith a non-imaging localization modality using a non-ionizing energy,wherein the marker is positioned within the patient; and developing atreatment plan for use over a plurality of treatment fractions using theobjective target data by inputting the parameter of the marker in thetreatment plan, wherein the radiation therapy includes continuoustreatment during the plurality of treatment fractions.
 2. The method ofclaim 1, further comprising obtaining images of the target and of themarker using an imaging modality before acquiring the objective targetdata, wherein the imaging modality is different than the localizationmodality used to acquire the objective target data.
 3. The method ofclaim 1 wherein (a) the target comprises a lesion, (b) a plurality ofmarkers are implanted relative to the lesion, and (c) the parameter ofthe target is at least one of the size, shape, rotation, and motion ofthe lesion, and wherein the method further comprises identifying achange in the parameter of the lesion by periodically locating theplurality of markers using the localization modality and determiningchanges in the relative distances between the markers.
 4. The method ofclaim 3, further comprising sending a warning message when the change inthe parameter of the lesion exceeds a predetermined value.
 5. The methodof claim 3, further comprising (a) sending a warning message when thechange in the parameter of the lesion exceeds a predetermined value, and(b) adapting the treatment plan for treating the lesion based on thechange in the parameter of the lesion.
 6. The method of claim 1 whereinthe physical parameter is a trajectory of the target caused by movementof the target within the patient, and the method further comprisesdetermining the trajectory using the periodic locations of the marker.7. The method of claim 6, further comprising sending a warning messagewhen the change in the target trajectory exceeds a predetermined value.8. The method of claim 6, further comprising (a) sending a warningmessage when the change in the target trajectory exceeds a predeterminedvalue, and (b) adapting the treatment plan for treating the target basedon the change in the target trajectory.
 9. The method of claim 1,wherein the non-ionizing energy is a magnetic field.
 10. The method ofclaim 1 wherein a tracking system that effectuates the localizationmodality is located in an assessment area separate from a radiationvault containing a radiation delivery device.
 11. The method of claim 1wherein the tracking system is located in a radiation treatment vaultcontaining a radiation delivery device.
 12. A method of developing atreatment plan for radiation therapy, comprising: periodically locatinga marker in a reference frame external to a patient with a non-imaginglocalization modality using a non-ionizing energy, wherein the marker ispositioned within the patient at a site relative to a target in thepatient; and simulating treatment using the periodic locations of themarker and a predetermined multi-fraction treatment plan wherein thesimulated treatment includes continuous treatment during themulti-fraction treatment plan.
 13. The method of claim 12 wherein (a)the target comprises a lesion, (b) a plurality of markers are implantedrelative to the lesion, and (c) the method further comprises determiningtarget data related to a parameter of the target by periodicallylocating the markers using the non-ionizing energy.
 14. The method ofclaim 13 wherein the parameter is at least one of the size, shape,rotation, and motion of the lesion, and wherein the method furthercomprises identifying a change in the parameter of the lesion bydetermining changes in the relative distances between the markers. 15.The method of claim 13, further comprising sending a warning messagewhen the change in the parameter of the lesion exceeds a predeterminedvalue.
 16. The method of claim 13, further comprising (a) sending awarning message when the change in the parameter of the lesion exceeds apredetermined value, and (b) adapting the treatment plan for treatingthe lesion based on the change in the parameter of the lesion.
 17. Themethod of claim 12, further comprising determining target data relatedto a parameter of the target by periodically locating the marker usingthe non-ionizing energy, wherein the parameter is a trajectory of thetarget caused by movement of the target within the patient.
 18. Themethod of claim 17, further comprising sending a warning message whenthe change in the target trajectory exceeds a predetermined value. 19.The method of claim 17, further comprising (a) sending a warning messagewhen the change in the target trajectory exceeds a predetermined value,and (b) adapting the treatment plan for treating the target based on thechange in the target trajectory.
 20. A method of developing a treatmentplan for radiation therapy, comprising: periodically locating aplurality of markers in a reference frame external to a patient with anon-imaging localization modality using a non-ionizing energy, whereinthe markers are positioned within the patient relative to a target inthe patient; characterizing a parameter of the target by comparingrelative positions between the markers; and inputting the parameter ofthe markers in a treatment plan, which spans multiple treatmentfractions, for irradiating the patient with an ionizing radiation beamwherein the radiation therapy includes continuous treatment during themultiple treatment fractions.
 21. The method of claim 20 wherein (a) thetarget comprises a lesion, (b) a plurality of markers are implantedrelative to the lesion, and (c) the parameter of the target is at leastone of the size, shape, rotation, and motion of the lesion, and whereinthe method further comprises identifying a change in the parameter ofthe lesion by periodically locating the plurality of markers using thelocalization modality and determining changes in the relative distancesbetween the markers.
 22. The method of claim 21, further comprisingsending a warning message when the change in the parameter of the lesionexceeds a predetermined value.
 23. The method of claim 21, furthercomprising (a) sending a warning message when the change in theparameter of the lesion exceeds a predetermined value, and (b) adaptingthe treatment plan for treating the lesion based on the change in theparameter of the lesion.
 24. A method for developing a treatment planfor treating a target within a patient using radiation therapy,comprising: periodically localizing a marker positioned within thepatient with a non-imaging localization system using non-ionizing energyto determine locations of the marker in a reference frame external tothe patient; determining a parameter of the target within the patientbased on the location of the marker in the reference frame; andinputting the parameter of the target into a treatment plan forirradiating the patient with an ionizing radiation beam wherein thetreatment plan is designed to cover multiple treatment fractions whereinthe radiation therapy treatment plan includes continuous treatmentduring the multiple treatment fractions.
 25. The method of claim 24wherein (a) the target comprises a lesion, (b) a plurality of markersare implanted relative to the lesion, and (c) the parameter of thetarget is at least one of the size, shape, rotation, and motion of thelesion, and wherein the method further comprises identifying a change inthe parameter of the lesion by periodically locating the plurality ofmarkers using the localization modality and determining changes in therelative distances between the markers.
 26. The method of claim 25,further comprising sending a warning message when the change in theparameter of the lesion exceeds a predetermined value.
 27. The method ofclaim 25, further comprising (a) sending a warning message when thechange in the parameter of the lesion exceeds a predetermined value, and(b) adapting the treatment plan for treating the lesion based on thechange in the parameter of the lesion.
 28. The method of claim 24wherein the physical parameter is a trajectory of the target caused bymovement of the target within the patient, and the method furthercomprises determining the trajectory using the periodic locations of themarker.
 29. The method of claim 28, further comprising sending a warningmessage when the change in the target trajectory exceeds a predeterminedvalue.
 30. The method of claim 28, further comprising (a) sending awarning message when the change in the target trajectory exceeds apredetermined value, and (b) adapting the treatment plan for treatingthe target based on the change in the target trajectory.
 31. A method ofdeveloping a treatment plan for radiation therapy, comprising: obtainingimages of a target in a patient and of a marker positioned within thepatient using an imaging modality; periodically locating the marker in areference frame external to the patient using a non-imaging localizationmodality different than the imaging modality; defining a parameter ofthe target based on the locations of the marker in the reference frame;and inputting the parameter of the target into a plan for controlling aradiation delivery device wherein the plan includes a multi-fractiontreatment plan wherein the radiation therapy includes continuoustreatment during the multi-fraction treatment.
 32. The method of claim31 wherein the imaging modality uses an ionizing radiation and thelocalization modality uses a non-ionizing radiation.
 33. The method ofclaim 31 wherein the localization modality comprises a magnetic field.34. A method for developing a treatment plan for radiation therapy,comprising: obtaining images of a target in a patient and of a markerpositioned within the patient using an imaging modality; periodicallylocating the marker in a reference frame external to the patient using anon-imaging localization modality different than the imaging modality;and instructing the patient to control a body function based on thelocations of the marker during a fractional treatment of the treatmentplan wherein the radiation therapy includes continuous treatment duringthe plurality of treatment fractions.
 35. A method for developing atreatment plan for radiation therapy, comprising: periodically locatinga marker positioned within a patient with respect to a reference frameexternal to the patient using a non-imaging localization modality; andtraining the patient to control a body function based on the periodiclocations of the marker in the reference frame during a fractionaltreatment of the treatment plan wherein the radiation therapy includescontinuous treatment during the plurality of treatment fractions.
 36. Amethod of integrating planning and setup procedures in radiationtherapy, comprising: developing a multi-fraction treatment plan fortreating a target within the patient by (a) periodically locating amarker positioned within the patient with respect to a reference frameexternal to the patient using a non-imaging localization modality and(b) determining target data based on the marker locations wherein theradiation therapy includes continuous treatment during the plurality oftreatment fractions; subsequently determining whether the target is inaccordance with the target data by periodically locating the marker on aday that the patient is scheduled to be irradiated using thelocalization modality; and positioning the patient in an externalreference frame of a radiation delivery device by periodically locatingthe marker in the external reference frame of the radiation deliverydevice.